MEDLINE URO175816TRecalls & reported problems
Medline Industries, Inc. · 1LYR TRY 16FR 10ML 100% SILTMP SNP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medline silicone Foley catheter (temp/Foley kit) is used for draining urine and, in some versions, reading body temperature. The 32 reports mostly describe the balloon or the tubing giving way — the balloon bursting or leaking, holes and punctures in the material, fluid leaking around the catheter, and catheters slipping out or failing to drain. Reports mention 12 injuries and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10193489988505), received between Jul 20, 2023 and Sep 21, 2026 — classified as 12 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (11 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem11
- Material Rupture4
- Appropriate Device Problem Term/Code Not Available3
- Device Sensing Problem3
- Leak/Splash2
- Material Puncture/Hole2
- Unintended Deflation2
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Foreign Body In Patient1
- Urinary Retention1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848009 ↗MalfunctionSep 21, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848007 ↗MalfunctionSep 21, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848006 ↗MalfunctionJan 19, 2026Unintended Deflation
ACCORDING TO THE FACILITY, THE TEMP FOLEY KIT WAS INSERTED IN PATIENT ON (B)(6) AM. THE PATIENT WENT TO THE OR FOR "EGD AND COLONOSCOPY" AND UPON ARRIVAL BACK TO THE ICU, THE URINE WAS LEAKING AROUND THE CATHETER AND REMOVED AND "IT EASILY SLID OUT OF THE URETHRA. BALLOON NOTED TO BE DEFLATED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111495 ↗MalfunctionJan 19, 2026Unintended Deflation
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE FOLEY CATHETER WAS READING THE PATIENT'S TEMPERATURE AT "84.5 DEG FAHRENHEIT", AND UPON FURTHER INSPECTION IT WAS DISCOVERED THAT THE CATHETER WAS NO LONGER INSIDE THE PATIENT, AND THE CATHETER WAS NOTED TO HAVE A "DEFLATED BALLOON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109296 ↗MalfunctionDec 15, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A FOLEY CATHETER WAS PLACED AND CAME OUT WHEN THE PATIENT WAS TURNED. AFTER REMOVAL, THE CATHETER BALLOON WAS CHECKED AND A STREAM OF SALINE WAS NOTED SHOOTING OUT SIDEWAYS AS IT WAS PUSHED INTO THE BALLOON. NO PATIENT HARM WAS IDENTIFIED AND A NEW FOLEY CATHETER WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809982 ↗InjurySep 11, 2025Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE FACILITY, THE FOLEY CATHETER WAS NOT DRAINING CORRECTLY. THE NURSE REMOVED THE CATHETER AND REPLACED WITH A NEW ONE.
Patient problems: Urinary Retention
MAUDE report 23032007 ↗InjuryMay 15, 2025Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THERE WAS "LEAKING AROUND THE CATHETER" NOTED BY THE CUSTOMER REQUIRING THE CATHETER TO BE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027163 ↗InjuryApr 28, 2025Material Integrity Problem; Material Integrity Problem
InjuryApr 28, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE FOLEY BALLOON RUPTURED "HOURS AFTER INSERTION". THE CUSTOMER REPORTED A NEW FOLEY CATHETER WAS INSERTED DUE TO THE REPORTED ISSUE. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY RELATED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Patient problems: Foreign Body In Patient
MAUDE report 21918761 ↗InjuryApr 25, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE FOLEY BALLOON RUPTURED "HOURS AFTER INSERTION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908716 ↗InjuryApr 24, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON 03/29/2025 THE FOLEY BALLOON RUPTURED "HOURS AFTER INSERTION". THE CUSTOMER REPORTED A NEW FOLEY CATHETER WAS INSERTED DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904111 ↗InjuryApr 24, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE FOLEY BALLOON RUPTURED "HOURS AFTER INSERTION". THE CUSTOMER REPORTED A NEW FOLEY CATHETER WAS INSERTED DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904086 ↗InjuryApr 3, 2025Leak/Splash; Leak/Splash
ACCORDING TO THE REPORT, ON (B)(6) 2025 THE PRODUCT WAS "LEAKING AROUND CATHETER" DURING INSERTION REQUIRING THE CATHETER TO BE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21765491 ↗InjuryApr 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6), THE PATIENT WAS HAVING A CATHETER INSERTED AT THE TIME OF THE BALLOON POPPING. THE CATHETER WAS REMOVED AND WAS REPLACED THE NEXT DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21754844 ↗MalfunctionFeb 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE CUSTOMER ON (B)(6) 2023, THE "TEMP SENSING CABLE CAME OUT OF FOLEY "SHREDDING FOLEY" WHILE IN A PATIENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18753810 ↗MalfunctionDec 21, 2023Material Integrity Problem; Material Integrity Problem
SAMPLE PORT DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18373013 ↗MalfunctionDec 21, 2023Material Integrity Problem; Material Integrity Problem
SAMPLE PORT DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371956 ↗InjuryDec 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON 11/27/23 "THE FOLEY WITH THE BROKEN TEMP PROBE WAS REMOVED AND A NEW CATHETER WAS INSERTED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18371778 ↗MalfunctionDec 20, 2023Material Integrity Problem; Material Integrity Problem
SAMPLE PORT DETACHED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18369654 ↗InjuryNov 30, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6). 2023 THE FOLEY CATHETER BALLOON RUPTURED REQUIRING THE FACILITY TO REPLACE THE CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18241872 ↗MalfunctionNov 21, 2023Inflation Problem; Inflation Problem
BALLOON DID NOT WORK (DIDN'T INFLATE) ON THIS CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182813 ↗MalfunctionSep 13, 2023Material Puncture/Hole; Material Puncture/Hole
"URINARY CATHETER BAG WITH 2 HOLES AND LEAKING URINE ".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17738236 ↗MalfunctionSep 13, 2023Material Integrity Problem; Material Integrity Problem
"TEMP SENSING INTERNAL THERMOMETER OF FOLEY PRODUCT BECAME DISLODGED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17736188 ↗InjuryAug 7, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON 07/12/2023 "A NURSE TOOK A SAMPLE WITH A SYRINGE FROM THE SAMPLING PORT AND THE BLUE PIECE IN THE MIDDLE FELL OF WHEN THE SYRINGE WAS PULLED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17470789 ↗
Other Catheter care tray devices
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- Bardia® Foley Catheter Insertion Tray 802010C. R. Bard, Inc. · Catheter care tray54 reports
- Medline DYND10160Medline Industries, Inc. · Catheter care tray1 recall4 reports
- Medline DYNC1816Medline Industries, Inc. · Catheter care tray1 recall2 reports
- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- MEDLINE URO4RR16CMedline Industries, Inc. · Catheter care tray1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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